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PharmacokineticsPhase 1NCT06471868

Study to Evaluate Pharmacokinetic and Pharmacodynamic Drug Interactions and Safety of IY-HCR21 and IY-MIC

A Phase 1 study testing IY-HCR21 and IY-MIC in people with Pharmacokinetics, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study evaluate the pharmacokinetic and safety of IY-HCR21 Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Pharmacokinetics
What is being tested?
IY-HCR21 and IY-MIC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSouth Korea
Study dates
10 Jun 2024to 2 Jul 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Volunteers aged 19 years and above at screening
  • A volunteer who weighs ≥ 50kg (≥ 45kg for women) and has a body mass index(BMI)* of ≥18.0 and ≤ 30 at screening
  • BMI(body mass index, kg/m^2)= Body weight (kg)/[height (m)^2]
  • No clinically significant congenital or treatment-requiring chronic medical conditions and no pathological symptoms or findings on internal medicine examination (including EEG, electrocardiogram, thoracic and gastroscopy or gastrointestinal radiology, if necessary)
  • A person who is determined by the principal investigator (or a physician delegated by the principal investigator) to be suitable as a patient as a result of diagnostic tests (e.g., haematology, blood chemistry, serology, urinalysis) and electrocardiograms (ECG) set and conducted according to the characteristics of the investigational drug at the time of screening.
  • Agree that they or their spouse or partner is using a medically accepted method of contraception* (but not hormonal agents) to exclude the possibility of pregnancy from the date of the first dose of investigational drug until 7 days after the last dose of investigational drug, and agree not to provide sperm or eggs
  • Signed the consent form freely and voluntarily after being fully informed and understanding the purpose, content, characteristics of the investigational drug, and expected adverse events of this study.

Who cannot join

  • Have taken drugs that induce or inhibit drug metabolising enzymes, such as barbiturates, within 30 days prior to study entry (first dose day) or have taken drugs that may interfere with this study within 10 days prior to study entry (first dose day)
  • Participated in a bioequivalence study or other clinical trial within 6 months prior to study initiation (first dose) and received an investigational product
  • blood donation within 8 weeks prior to study entry (first dose day) or component donation within 2 weeks
  • Have a history of gastrointestinal surgery (except appendectomy and hernia surgery) that may affect the absorption of the drug
  • Excessive alcohol consumption within 1 month prior to study entry (first dose day)
  • Patients with any of the following conditions
Show all 25Show fewer
  • Patients with mechanical obstruction of the gastrointestinal tract or urinary tract
  • spastic gastrointestinal diseases, stomach ulcers, acute inflammatory diseases of the gastrointestinal tract
  • Patients with peritonitis
  • Patients with vasovagal dystonia
  • Patients with asthma
  • Patients with hyperthyroidism
  • Patients with coronary artery occlusion
  • Bradycardia, atrioventricular conduction disorder, vasomotor instability
  • Hypotension, hypertension
  • Patients with myocardial infarction, severe heart disease
  • Patients with epilepsy and parkinsonism
  • Patients treated with anticholinesterase agents
  • Patients with unhealed gastrointestinal anastomoses
  • Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • Patients who are hypersensitive to or have a history of allergy to Yellow No. 4 (tartrazine)
  • Patients with a history of hypersensitivity to any of the main ingredients or excipients of this medicine
  • Have a history of clinically significant psychiatric disorders
  • For reasons other than the above inclusion/exclusion criteria, the principal investigator (or delegated investigator) deems the subject unsuitable for this study.
  • For female volunteers, suspected pregnancy or lactation

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • H plus Yangji Hospital

    Seoul, Gwanak-gu, 08756

Other trials in South Korea

About this study

Official title: An Open-label, Randomized, Multiple-dose, 2-sequence, 2-period, Crossover, Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetics of IY-HCR21 Compared to IY-MIC in Healthy Adult Volunteers

This study evaluate the pharmacokinetic and safety of IY-HCR21

Read the detailed description

Phase 1 study to evaluate the safety and the pharmacokinetics of IY-HCR21 in healthy adult volunteers under multiple-dose condition

Being tested
IY-HCR21, IY-MIC
Keywords
a parasympathomimetic choline carbamate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IY-HCR21Drug

    Betanechol 50mg

  • IY-MICDrug

    Betanechol 25mg

Study groups in NCT06471868
Study groupRoleWhat they receive
A groupActive comparatorPeriod 1 : IY-HCR21 1Tab, BID Period 2 : IY-MIC 1Tab, QID
Receives: Drug: IY-HCR21; Drug: IY-MIC
B groupActive comparatorPeriod 1 : IY-MIC 1Tab, QID Period 2 : IY-HCR21 1Tab, BID
Receives: Drug: IY-HCR21; Drug: IY-MIC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Betanechol AUCt,ss

    Betanechol AUCt,ss(Area under the plasma drug concentration-time curve in steady state)

    Measured: Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)

  2. Betanechol Cmax,ss

    Betanechol Cmax,ss (Maximum plasma concentration in steady state)

    Measured: Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)

Secondary outcomes (6)

  1. AUCinf

    Betanechol AUCinf(Area under the plasma drug concentration-time curve from time 0 to infinity)

    Measured: Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)

  2. t1/2

    Betanechol t1/2(Terminal half-life)

    Measured: Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)

  3. Tmax,ss

    Betanechol Tmax,ss(Time to maximum plasma concentration in steady state)

    Measured: Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)

  4. AUCt/AUCinf

    Betanechol AUCt/AUCinf

    Measured: Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)

  5. AUC24

    Betanechol AUC24 (Area Under the Plasma Concentration-Time curve in 24hour)

    Measured: Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24)

  6. Cmin,ss

    Betanechol Cmin,ss (Minimum plasma concentration in steady state)

    Measured: Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2024
  2. Study start10 Jun 2024
  3. Primary completion25 Jun 2024 (estimated)
  4. Study completion2 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06471868
Sponsor's protocol ID
IY-HTBC01
Status last verified
Jun 2024
First submitted
18 Jun 2024
Last updated
24 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IY-HCR21 and IY-MIC in people with Pharmacokinetics, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Betanechol AUCt,ss (time frame: Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06471868.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.

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